NicOx S.A. (Euronext Paris: COX) today announced positive top-line resultsfrom a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the111 study), which compared the 24-hour blood pressure profile of escalatingdoses of naproxcinod and naproxen in osteoarthritis (OA) patients withcontrolled hypertension. The primary ABPM parameter was the mean 24-hourambulatory systolic blood pressure (SBP) measured by ABPM over the wholestudy period and naproxcinod showed a statistically significant decrease inSBP of 3.8 mmHg (p < > =0.011) compared to naproxen. Furthermore, incontrast to naproxen, naproxcinod reduced the mean 24-hour SBP anddiastolic blood pressure (DBP) from baseline at every dose comparison. Goodsafety and tolerability were shown by all naproxcinod doses. NicOx plans toprovide further details of the results at a leading cardiology conferencein 2009.

Naproxcinod is the first investigational drug in the newCyclooxygenase-Inhibiting Nitric Oxide-Donator (CINOD) class ofanti-inflammatory agents, which is nearing the end of phase 3 clinicaldevelopment for the treatment of the signs and symptoms of osteoarthritis,with the submission of a New Drug Application (NDA) with the US Food andDrug Administration (FDA) projected for mid-2009. NicOx expects to have theresults of a second large ABPM study in patients with hypertension and OA(112) before the end of 2008, in addition to the results of the remainingpivotal phase 3 trial in hip OA (303).

COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs(NSAIDs), such as naproxen and ibuprofen, are widely used as symptomatictreatments for OA. However, they can cause new episodes of high bloodpressure and destabilize previously controlled hypertensive patients, whichis a particular concern in the OA population where approximately 50% ofpatients are estimated to be hypertensive.

"These impressive results suggest that naproxcinod could represent avaluable treatment alternative for osteoarthritis patients," said RaymondTownsend, Professor of Medicine at the University of Pennsylvania, whoadvised NicOx on the design and analysis of the study. "The hypertensiveside effects of COX-2 inhibitors and traditional NSAIDs are a seriousmedical issue and there is a clear need for a new drug with no detrimentaleffect on blood pressure. These ABPM data have been obtained in a relevantpopulation of chronically treated osteoarthritis patients with manycardiovascular risk factors and clearly show a consistent beneficial effecton blood pressure for naproxcinod across the dose range, in contrast tonaproxen. In addition, the use of the ABPM technique gives themconsiderable weight, as it is widely recognized as the gold standard methodfor assessing the blood pressure profile of new drugs."

The 111 study design and results

In the study, 118 patients were randomized on a 1:1 basis to receivenaproxcinod or naproxen, with escalating doses every three weeks. The trialincluded three doses of naproxcinod (375 mg bid, 750 mg bid and asupra-therapeutic dose of 1125 mg bid), which were compared to naproxen(250, 500 and 750 mg bid). 24-hour blood pressure monitoring was conductedat baseline and at the end of each three-week dose escalation (i.e. at theend of week 3, 6 and 9), using an FDA validated, ABPM device.

The primary objective of the study was to characterize the 24-hour arterialblood pressure profile of the three doses of naproxcinod, as measured byABPM after each dose, compared to naproxen. At all time points, naproxcinodshowed a decrease in the mean 24-hour SBP and DBP from baseline in contrastto naproxen. In terms of the overall treatment effect, as an average overweek 3, 6 and 9, naproxen raised SBP by 1.5 mmHg from baseline, whilenaproxcinod lowered it by 2.3 mmHg, resulting in a difference between thetwo treatments of 3.8 mmHg (p < > =0.011) in favor of naproxcinod.

Michele Garufi, Chairman and CEO of NicOx, commented: "These excellentresults are an important addition to the consistent data we areaccumulating on naproxcinod's potentially non-detrimental blood pressureprofile and its clear differentiation from naproxen. We are confident thatnaproxcinod's potential will be confirmed by the further clinical resultsexpected in the coming months."

The three doses of naproxcinod showed good general safety and tolerability.In the naproxcinod arm 32 patients (54.2%) experienced one or more adverseevents, compared to 38 patients (64.4%) in the naproxen arm. There were noserious adverse events in the naproxcinod arm.

Additional note on study design: The 111 study was a 12-weekpharmacodynamic ABPM trial (with 9 weeks of active treatment), with adouble-blind, parallel group design, in which 118 OA patients withcontrolled hypertension were enrolled at 30 clinical sites in the UnitedStates. Eligible patients were 40 years and older and had been sufferingfrom osteoarthritis for at least three months, with at least one hip orknee involved. In addition to OA, all patients were diagnosed withcontrolled essential hypertension (i.e. SBP < 140 mmHg and DBP < 90 mmHg)and were treated with stable doses of up to two different classes ofantihypertensive agents. Patients with uncontrolled hypertension wereexcluded.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) a product-drivenbiopharmaceutical company dedicated to the development and futurecommercialization of investigational drugs for unmet medical needs. NicOxis applying its proprietary nitric oxide-donating technology to develop aninternal portfolio of New Chemical Entities (NCEs) in the therapeutic areasof inflammatory and cardio-metabolic disease.

Resources are focused on the development of naproxcinod, a proprietary NCEand the first compound in the Cyclooxygenase-Inhibiting NitricOxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase3 clinical studies for the treatment of the signs and symptoms ofosteoarthritis, with final phase 3 results anticipated in 2008.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitricoxide-donating NCEs, which are in development internally and with partners,including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalentand underserved diseases, such as atherosclerosis, hypertension, widespreadeye diseases and Chronic Obstructive Pulmonary Disease (COPD).

NicOx S.A. is headquartered in France and is listed on the Euronext ParisStock Exchange (Compartment B: Mid Caps).

This press release contains certain forward-looking statements. Althoughthe Company believes its expectations are based on reasonable assumptions,these forward-looking statements are subject to numerous risks anduncertainties, which could cause actual results to differ materially fromthose anticipated in the forward-looking statements.

For a discussion of risks and uncertainties which could cause actualresults, financial condition, performance or achievements of NicOx S.A. todiffer from those contained in the forward-looking statements, please referto the Risk Factors ("Facteurs de Risque") section of the Document deReference filed with the AMF, which is available on the AMF website(http://www.amf-france.org) or on NicOx S.A.'s website(http://www.nicox.com).

CONTACTS: http://www.nicox.com

NicOx: Karl Hanks Director of Investor Relations and CorporateCommunication

Tel +33 (0)4 97 24 53 42 - hanks@nicox.com

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